Director, Diagnostics - Rare Disease CDx Strategy

Alexion Pharmaceuticals, Inc.; Boston (MA); Hybrid; USD 181,000 - 271,000; Full time

Benefits offered by this job

Retirement benefits

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca is seeking a Director of Diagnostics to lead the Center of Excellence across a rare disease portfolio in Boston. You will shape end-to-end diagnostic approaches from late discovery through lifecycle management, coordinating with translational science, regulatory, and clinical teams to accelerate trial readiness and product approvals.

You will own trial-level diagnostic strategies, drive CDx partnerships, and ensure global regulatory readiness while building capabilities and

Qualifications

• Advanced degree (PhD or equivalent) in a relevant scientific field.
• 10+ years in precision medicine/diagnostics within pharma/biotech, discovery to launch.
• Proven track record leading diagnostic strategy and CDx development.
• Experience with global regulatory pathways (FDA IDE/PMA; EU IVDR CPS).

Responsibilities

• Define disease-specific diagnostic strategies aligned to patient journey.
• Own trial-level diagnostic strategies and lead CDx development with partners.
• Ensure timely regulatory submissions and compliance across regions.
• Translate biomarker hypotheses into robust validation plans.

Skills

Cross-functional leadership

Regulatory pathways

Biomarker validation

CDx development

Vendor management

Education

PhD in a relevant scientific field

Job description

AstraZeneca is seeking a Director of Diagnostics to lead the Center of Excellence across a rare disease portfolio in Boston. You will shape end-to-end diagnostic approaches from late discovery through lifecycle management, coordinating with translational science, regulatory, and clinical teams to accelerate trial readiness and product approvals.

You will own trial-level diagnostic strategies, drive CDx partnerships, and ensure global regulatory readiness while building capabilities and